CHUNZAM BIO CO., LTD. · 66-79 · KOREA (THE REPUBLIC OF)
For CHUNZAM BIO CO., LTD. · 66-79 · KOREA (THE REPUBLIC OF), import alert is 66-79; import alert name is "Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection"; country is KOREA (THE REPUBLIC OF); product is All Drug and Drug Products; product code is 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs; date published is 10/13/2022; address is 225 Wangsan-Ro , Dongdaemun, Seoul KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- CHUNZAM BIO CO., LTD. verified
- Import alert
- 66-79
- Import alert name
- "Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection"
- Country
- KOREA (THE REPUBLIC OF) verified
- Address
- 225 Wangsan-Ro , Dongdaemun, Seoul KOREA (THE REPUBLIC OF) verified
- Date published
- 10/13/2022 verified
- Product code
- 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs each item verified
- Product
- All Drug and Drug Products verified
- FDA notes
- For 53I[][]01; only drug and drug products are subject to DWPE under this notice.; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 each item verified
What the source says
CHUNZAM BIO CO., LTD. Date Published : 10/13/2022 225 Wangsan-Ro , Dongdaemun, Seoul KOREA (THE REPUBLIC OF) 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) Date Published: 10/28/2021 Desc: All Drug and Drug Products Notes: For 53I[][]01; only drug and drug products are subject to DWPE under this notice.; DWPE Date; 10/24/2018 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018 56 - - - -- Antibiotics (Human/Animal) Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018 61 - - - -- Human and Animal Drugs Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018 62 - - - -- Human and Animal Drugs Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018 63 - - - -- Human and Animal Drugs Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018 64 - - - -- Human and Animal Drugs Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018 65 - - - -- Human and Animal Drugs Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018 66 - - - -- Human and Animal Drugs Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1174.html